A Randomized, Open-Label, Controlled Study to Evaluate the Effects of a Prebiotic Soda on Glycemic Control in Adults With Glucose Dysregulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Effects on Fasting Plasma Glucose
研究概览
简要总结
The main objective of this study is to evaluate the chronic effects of replacing traditional non-diet soda with a prebiotic soda on biomarkers associated with glycemic control in adults with glucose dysregulation who are habitual consumers of traditional soda.
详细描述
The primary aim of this clinical trial is to evaluate the effects of replacing traditional non-diet soda with a prebiotic soda (i.e., OLIPOP) over an 8 week period on markers of glucose (blood sugar) control in adults with glucose (blood sugar) dysregulation.
Participants (n=224) will be habitual consumers of traditional non-diet sodas, consuming on average 2-3 servings of non-diet soda daily. Participants will be randomized to either an active control group (continued habitual traditional non-diet soda intake, 2 - 3 servings/day) or a behavioral intervention group (OLIPOP prebiotic soda, 2 cans/day (24 fl. oz/day), 6 g dietary fiber and 2 - 5 g total sugar per 12 fl. oz can).
Secondary outcomes will include evaluating the effects of prebiotic soda consumption on additional markers of metabolic health, including long-term glycemic control and insulin sensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to provide informed consent
- •Willing to comply with all study procedures
- •Male or female, ages 30 - 70 years old
- •Habitual consumers of traditional non-diet soda (average intake 2 - 3 servings (24-36 fl. oz)/daily in a typical month, representing usual dietary pattern)
- •BMI between 25 - 35 kg/m²
- •Fasting plasma glucose between 100 - 125 mg/dL or hemoglobin A1c between 5.7% - 6.4%
- •Low habitual dietary fiber intake, assessed using a qualitative fiber intake screening questionnaire administered at pre-screening
- •Willing to maintain stable tobacco/nicotine use habits established for ≥ 90 days, with no initiation, cessation, or change in frequency during the study period
- •Willing to maintain stable marijuana, hemp, and CBD product use habits established for ≥ 60 days, with no initiation, cessation, or change in frequency during the study period
- •Willing to maintain habitual diet (with the exception of study products) and physical activity patterns throughout the trial
排除标准
- •Inability to consume a standard 12 fl. oz. carbonated beverage twice daily
- •Currently engaged or planning to be on an intensive weight loss regimen program
- •Extreme dietary habits in the judgement of the Investigator or has been diagnosed with an eating disorder
- •Habitual use of fiber supplements, inulin-based supplements, acacia fiber, glucomannan, prebiotic supplements, or probiotic supplements within 30 days of study enrollment
- •Known allergy or sensitivity to any of the ingredients in the study products
- •History or presence of uncontrolled and/or clinically important medical conditions that could interfere with study results interpretation (i.e., diabetes mellitus, CKD stage 4-5, severe liver disease/cirrhosis, uncontrolled hypertension, recent myocardial infarction or stroke (within 6 months), severe mental illness or cognitive impairment, immunodeficiency disorders, active infections).
- •Gastrointestinal conditions that could potentially interfere with absorption of the study product (i.e., IBD, celiac disease, short bowel syndrome, chronic pancreatitis, gastroparesis, active peptic ulcer disease, gastric bypass or other bariatric surgeries, severe IBS, chronic diarrhea or malabsorption syndromes, active diverticulitis)
- •Use of oral or injectable steroids within 90 days of enrollment
- •Use of antibiotic therapy within 90 days of enrollment
- •Unstable use of prescription medications within 90 days of enrollment that affect plasma glucose levels (e.g., corticosteroids, thiazide diuretics, beta-blockers (some types), antipsychotics, tacrolimus, protease inhibitors, ACE inhibitors)
- •Use of any of the following prescription medications within 90 days of enrollment: Metformin, sulfonylureas, GLP-1 agonists, SGLT-2 inhibitors, insulin.
- •History or presence of cancer, except non-melanoma skin cancer, within 2 years of enrollment
- •Exposure to any non-registered drug product or participation in another intervention study within 30 days prior to enrollment
- •Recent history (within 12 months) of alcohol or substance abuse
- •History of major trauma or surgical event within 60 days of enrollment
- •Person who is pregnant, planning pregnancy, or lactating
- •Any condition the Investigator believes would interfere with study participation or compliance
- •Consumption of more than 5 prebiotic sodas within the last 30 days prior to enrollment
- •Heavy smoker as defined as smoking 20 or more cigarettes per day, or smoked roughly 1 pack a day for 20+ years (more than 20 pack years)
研究组 & 干预措施
Intervention
Participants will be randomized to replace traditional non-diet soda with prebiotic soda
干预措施: Prebiotic Soda (Behavioral)
Control Group
Participants will be randomized to continue consumption of traditional non-diet soda.
干预措施: Active Control (Behavioral)
结局指标
主要结局
Effects on Fasting Plasma Glucose
时间窗: Baseline to 8 weeks
Change in fasting plasma glucose
次要结局
- Effects on Long-term Glycemic Control(Baseline to week 8)
- Effect on insulin sensitivity(Baseline to week 8)